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510(k) Data Aggregation
K Number
K202972Device Name
Anterior Cervical Plate System
Manufacturer
Date Cleared
2020-11-24
(55 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Nutech Spine and Biologics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nutech Spine and Biologics Anterior Cervical Plate System is interior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
Device Description
The Anterior Cervical Plate System consists of single level titanium bone plates of various sizes and titanium bone screws in various diameters and lengths to allow for patient specific configurations. The triangular shape of the plate allows for adjacent level fusion without removal of prior Nutech Cervical Plates. Implants are made from Ti 6AI4V ELI, per ATSM F136. The instrumentation allows for simple preparation and placement of the implant construct.
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